ADHD, Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, Attention Deficit Hyperactivity Disorder, Daytrana, MTS Patch, Methylphenidate Transdermal System
Brief summary
The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.
Interventions
Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)
DRUGPlacebo
Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Male and female outpatients 6 to 12 years of age. * Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview. * Participation in structured morning routine (e.g. school, camp, or other organized activities).
Exclusion criteria
* Mental retardation (IQ \<75). * Subjects with a medical condition, or treatment that will either jeopardize subject safety or affect the scientific merit of the study. * Subjects with moderate to severe dermatological atopy. * Subjects with known structural cardiac abnormalities. * Organic brain disorders. * Seizure Disorder. * Subjects with Tourette's syndrome, or a history of psychosis or bipolar disorder. * Subjects with current comorbid psychopathology that in the investigator's opinion will warrant immediate treatment or will interfere with the safe execution of the protocol (i.e. Anxiety or Major Depressive Disorder rated as moderate on CGI). * Subjects with a history of intolerable adverse effects or non-response to methylphenidate. * Pregnant or nursing females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. | Baseline and 4 weeks | Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe). |
| Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. | Baseline and 4 weeks | Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires | Baseline and 4 weeks | The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian. Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88 |
Countries
United States
Participant flow
Pre-assignment details
36 subjects signed consent, and 6 discontinued/withdrew consent prior to completing one week of treatment. The remaining 30 subjects were included in data analyses and thus reported.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Worsening behavior | 1 | 0 |
| Second Intervention | Adverse Event | 0 | 1 |
| Second Intervention | Withdrawal by Subject | 1 | 0 |
| Second Intervention | Worsening behavior | 1 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 30 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 9.17 years STANDARD_DEVIATION 1.84 |
| Attention Deficit Hyperactivity Disorder Rating Scale | 37.80 Units on a scale STANDARD_DEVIATION 9.08 |
| Attention Deficit Hyperactivity Disorder Rating Scale - AM | 30.83 Units on a scale STANDARD_DEVIATION 11.53 |
| Before-School Functioning Questionnaire | 40.50 Units on a Scale STANDARD_DEVIATION 11.64 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 30 | 7 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
Primary
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.
Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MTS (Drug A) | Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. | 10.03 Units on a scale | Standard Deviation 13.18 |
| Placebo | Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. | 23.22 Units on a scale | Standard Deviation 14.91 |
p-value: 0.003Z-test
Primary
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.
Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MTS (Drug A) | Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. | 14.76 Units on a scale | Standard Deviation 14.48 |
| Placebo | Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. | 28.33 Units on a scale | Standard Deviation 15.75 |
p-value: <0.001Z-test
Secondary
Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires
The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian. Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MTS (Drug A) | Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires | 12.76 Units on a scale | Standard Deviation 16.65 |
| Placebo | Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires | 31.37 Units on a scale | Standard Deviation 17.79 |
p-value: 0.001Z-test